The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.

Original Secondary Outcome Measures ICMJE (submitted: April 12, 2010)

Efficacy [ Time Frame: One year ] [ Designated as safety issue: No ]

The magnitude of the pre-post effect across 4 weeks of treatment. The magnitude of the difference between non-deceptive antidepressant placebo and waitlist

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Pilot Study of Open-label Placebo to Treat Major Depressive Disorder

Official Title ICMJE

Harnessing the Placebo Effect in Major Depressive Disorder

Brief Summary

Placebo pills (pills with no active ingredients) have been shown in research studies to somehow produce self-healing processes. The purpose of this study is to determine whether people will be willing to enter an open-label non-deceptive placebo treatment for Major Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in the context of a supportive physician-patient relationship.

Current use of other psychotropic drugs. Exception: Patients who have been on a stable dose for 30 days of classes of medications such as non-benzodiazepine sedatives, anxiolytic benzodiazepines, non-narcotic analgesics may be included. Flexibility will be allowed based on physician discretion.

Clinical or laboratory evidence of hypothyroidism.

Patients who have taken an investigational psychotropic drug within the last year.

Patients who have not responded to two or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g.,for six weeks or more) over the past five years.

Any concomitant form of psychotherapy (depression focused)

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects